Immucor's HEA test, which received CE Mark in July 2010 and is commercially available in Europe and other international markets, is currently available for Research Use Only in the United States. The HEA BeadChip product is an in vitro diagnostic test and is Immucor's core molecular test for extended typing of red blood cell antigens from a DNA sample. The product is designed to predict the phenotypes of the Rh (C,c,E,e), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Duffy, Kidd, MNS, Lutheran, Dombrock (Doa, Dob, Hy, Jo), Landsteiner-Wiener, Diego, Colton, and Scianna blood group systems. The test is also designed to detect a mutation (HgbS 173 A > T) in the Beta Globin gene. More than 700,000 tests have been processed with Immucor's HEA assay worldwide.
"We are pleased with the outcome of today's BPAC meeting for our HEA BeadChip product, which represents the first molecular immunohematology test to be accepted for review by FDA," stated Joanne Spadoro, PhD, Immucor's Chief Scientific Officer and Vice President of Research and Development. "Molecular methods are intended to provide additional information regarding the composition of donor and patient blood, which may result in better matches, especially for multi-transfused patients, such as those suffering from cancer and sickle cell disease."
Immucor submitted its Pre-Market Approval (PMA) application to the FDA in June 2013 for the HEA Molecular BeadChip Test. The FDA will take into account the BPAC's advice in making its decision on whether to approve the HEA BeadChip Test for blood group typing in the United States. The Company expects a decision on approval later this year.
The BPAC reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology that are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which the FDA has regulatory responsibility, and advises the Commissioner of Food and Drugs of its findings.